[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.4500]

[Page 356]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 876.4500  Mechanical lithotriptor.

    (a) Identification. A mechanical lithotriptor is a device with steel 
jaws that is inserted into the urinary bladder through the urethra to 
grasp and crush bladder stones.
    (b) Classification. Class II (performance standards).